Regulation – Page 2

Medical DevicesJanuary 10, 2023

MDCG Proposes a Potential One-Year Extension for Medical Devices

The Medical Device Coordination Group (MDCG) has released a new position paper, which reviews the means by which Article 97 of the Medical Device Regulation (MDR) can be applied to devices that have not been certified under the MDR. The paper states that the decision on whether to allow a device to remain on the market is up to the competent authority (CA) of record for the device, and that the device manufacturer may have only a one-year grace period before it will have to obtain a new marketing authorization under the MDR.

Medical Devices SaMDDecember 13, 2022

FDA Pilot SaMD Precertification Program Offers Few Insights

Many expected the FDA pilot program for software precertification to be a potential solution to many of the problems with the agency’s regulation of software as a medical device (SaMD). Unfortunately, it appears the precertification pilot was less than successful in providing a new regulatory path forward.

Medical DevicesNovember 29, 2022

IMDRF Issues Two-Part Guidance for Personalized Medical Devices

The International Medical Device Regulators Forum has produced a final working draft for verification and validation (V&V) of a personalized medical device (PMD), a much-needed source of regulatory harmonization. The document also addresses V&V for the medical device production system (MDPS) that will be used to manufacture PMDs.

Medical Devices SaMDOctober 19, 2022

FDA Final Guidance for CDS a Drastic Rewrite of Draft

Most FDA final guidances offer little more than a modest rewrite of the draft, but the FDA’s final guidance for clinical decision support (CDS) software represents a significant revision of the draft version. The changes seen in the final guidance may alter the regulatory status of both existing and developmental products, and developers of CDS software may wish to reevaluate their products in light of this new guidance.

Medical DevicesSeptember 28, 2022

FDA Draft Guidance for Computer Software Assurance a Fresh Look at Risk

Thanks to an ongoing controversy over computer system validation (CSV) for non-device software, the FDA draft guidance for computer software assurance (CSA) might be one of the most widely anticipated drafts to come out of the agency in several years. The key point is that the FDA explicitly acknowledges that software used in production and compliance systems does not necessarily present a high degree of risk, a key concession for those who believe the standing approach to compliance is often a case of regulatory overkill.

PharmaSeptember 22, 2022

ICH Expands on Analytical Methods Validation in Draft – Q2 Update

The FDA has released a second guidance from the International Council for Harmonization (ICH) related to analytical methods used in drug products, which is open for comment through Sept. 28, 2022. This latest version of the ICH Q2 series of guidances offers substantially greater detail than the previous version, suggesting that managers of drug manufacturing facilities should begin examining this policy on analytical methods validation to ensure the facility is prepared for the final version.

Medical DevicesAugust 22, 2022

MDCG Warning Letter to Industry: No More MDR Delays

The European Union has undertaken several measures to address the difficulty of implementing the Medical Device Regulation (MDR), but these grace periods are coming to an end. The EU’s Medical Device Coordination Group (MDCG) recently advised medical device manufacturers that time is running out to reapply for a CE mark for existing devices in a position paper that serves as a warning that stragglers may be left out in the transition.‍

Medical DevicesApril 12, 2022

FDA’s Cybersecurity Premarket Draft a Significant Rewrite

The FDA has reissued draft guidance for premarket cybersecurity considerations four years after the previous draft guidance, and eight years after the issuance of the most recent final guidance. While this draft guidance is not the final word on this policy, we would advise our clients that it represents a fundamental shift in the agency’s approach to cybersecurity, one that comes with a substantially more demanding set of requirements in the premarket phase of device development.

Digital HealthJanuary 1, 2022

Digital Tech for Clinical Trials May Carry Hefty Compliance Requirements

The FDA’s new draft guidance for the use of digital health technologies (DHTs) for remote data acquisition in clinical trials promises to help advance the market for a wide range of products in the digital health space. However, developers of these products should be aware that their products will be subject to a substantial amount of verification and validation work, along with a considerable load of usability studies.

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